(90 days)
Not Found
No
The document describes a standard electronic muscle stimulator with pre-set modes and intensity controls. There is no mention of adaptive algorithms, learning capabilities, or any terms associated with AI/ML. The performance studies focus on electrical safety, EMC, biocompatibility, usability, and software verification/validation according to standard medical device software guidance, not AI/ML specific testing.
Yes
The device is described as an Electronic Muscle Stimulator with TENS and PMS functions, intended for temporary pain relief and muscle stimulation, which are therapeutic applications.
No
The device is described as an "Electronic Muscle Stimulator" intended to stimulate healthy muscles to improve performance (PMS) and provide temporary pain relief (TENS) by applying electrical current. Its function is to deliver therapy, not to identify or diagnose a disease or condition.
No
The device description clearly outlines a physical device with hardware components such as electrode pads, wires, an adapter, a remote controller, buttons, and a display screen, which deliver electrical pulses. While software is mentioned for verification and validation, the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for stimulating muscles and providing temporary pain relief. These are therapeutic and physical stimulation purposes, not diagnostic testing performed on samples taken from the human body.
- Device Description: The description details an electronic stimulator that applies electrical pulses to the skin via electrodes. This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the device is a therapeutic and pain relief device that works by applying electrical stimulation to the body, which is fundamentally different from an in vitro diagnostic device that analyzes samples outside the body to provide diagnostic information.
N/A
Intended Use / Indications for Use
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
Electronic Muscle Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Electronic Muscle Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The models AST-300A and AST-300W have 9 buttons which is more than other models. Compared with other models, the "Time+" and "Time-" buttons are used to adjust the treatment time.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application model. The device is equipped with accessories of electrode pads, electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, back of the neck, arm, leg, and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted to verify that the subject device met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Usability test according to IEC 62366-1 standard
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 5, 2021
Shenzhen OSTO Technology Company Limited % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou City Guangdong, China
Re: K211736
Trade/Device Name: Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: May 31, 2021 Received: June 7, 2021
Dear Cassie Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211736
Device Name
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300T, AST-300T, AST-300V, AST-300W)
Indications for Use (Describe)
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
| Type of Use (Select one or both, as applicable) |
|---|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for K211736
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- 510(k) Owner's Name: Shenzhen OSTO Technology Company Limited �
- Establishment Registration Number: 3011564440 �
- � Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen City, Guangdong Province, China
- Tel: +86-755-29769546 �
- � Fax: +86-755-29769540
- Contact Person: Li Yang (General Manger) �
- � Email: annaosto@163.com
Application Correspondent: 2.
- � Contact Person: Ms. Cassie Lee
- Guangzhou GLOMED Biological Technology Co., Ltd. �
- � Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China
- Tel: +86 20 8266 2446 �
- Email: regulatory@glomed-info.com �
3. Subject Device Information
- Electronic Muscle Stimulator � Trade Name:
- Electronic Stimulator Common Name: �
- Stimulator, Nerve, Transcutaneous, Muscle, Powered, For �
- Classification name: Muscle Conditioning, Over-The-Counter
- Neurology, Physical Medicine Review Panel: �
ll
- NUH, NGX Product Code: �
- � Regulation Class:
- 882.5890, 890.5850 Regulation Number: �
4. Predicate Device Information
- Sponsor Shenzhen OSTO Technology Company Limited � Health Expert Electronic Stimulator � Device Name and Model Model: AST-300F, AST-300H, AST-300J
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- 510(k) Number K190673 �
- NUH, NGX Product Code �
- � Regulation Number 882.5890, 890.5850
- � Requlation Class II
2. Device Description
Electronic Muscle Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Electronic Muscle Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The models AST-300A and AST-300W have 9 buttons which is more than other models. Compared with other models, the "Time+" and "Time-" buttons are used to adjust the treatment time.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application model. The device is equipped with accessories of electrode pads, electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
5. Intended Use / Indications for Use
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
6. Test Summary
6.1 Non-clinical testing was conducted to verify that the subject device met all design specifications, demonstrated safety based on current industry standards, and to
5
demonstrate substantial equivalence to the predicate. The following tests were performed:
Electronic Muscle Stimulator has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 � standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to IEC 62366-1 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"
6.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electronic Muscle Stimulator is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of Comparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Device Name and Model | Electronic Muscle | |||
| Stimulator | ||||
| Model: AST-300A, | ||||
| AST-300N, AST-300S, | ||||
| AST-300T , AST-300V, | ||||
| AST-300W | Health Expert Electronic | |||
| Stimulator | ||||
| Model: AST-300F, | ||||
| AST-300H, AST-300J | -- | |||
| 510(k) Number | Applying | K190673 | -- | |
| Intended Use | PMS (Mode 1~8) | |||
| It is intended to stimulate | ||||
| healthy muscles in order | ||||
| to improve and facilitate | ||||
| muscle performance. | ||||
| TENS (Mode 9~25) | PMS (Mode 1~8) | |||
| It is intended to stimulate | ||||
| healthy muscles in order to | ||||
| improve and facilitate | ||||
| muscle performance. | ||||
| TENS (Mode 9~25) | SE | |||
| Elements of Comparison | Subject Device | Predicate Device | Remark | |
| To be used for temporary | ||||
| relief of pain associated | ||||
| with sore and aching | ||||
| muscles in the shoulder, | ||||
| waist, back, back of the | ||||
| neck, arm, leg, and foot | ||||
| due to strain from | ||||
| exercise or normal | ||||
| household work activities | ||||
| by applying current to | ||||
| stimulate nerve. | To be used for temporary | |||
| relief of pain associated | ||||
| with sore and aching | ||||
| muscles in the shoulder, | ||||
| waist, back, back of the | ||||
| neck, arm, leg, and foot due | ||||
| to strain from exercise or | ||||
| normal household work | ||||
| activities by applying | ||||
| current to stimulate nerve. | ||||
| Power Source(s) | Adaptor Input: | |||
| 100-240Vac, 50-60Hz, | ||||
| 0.1A | ||||
| Output: 5Vdc, 1A | ||||
| Unit Input: 5Vdc, 1A | Adaptor Input: 100-240Vac, | |||
| 50-60Hz, 0.1A | ||||
| Output: 5Vdc, 1A | ||||
| Unit Input: 5Vdc, 1A | SE | |||
| -Method of Line Current Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient Leakage | ||||
| Current | NC | AC: 54.5 $\mu$ A, DC: 0 $\mu$ A | AC: 54.5 $\mu$ A, DC: 0.5 $\mu$ A | SE |
| SFC | AC:120.0 $\mu$ A, DC: 0 $\mu$ A | AC:120.0 $\mu$ A, DC: 0.6 $\mu$ A | ||
| Average DC current through | ||||
| electrodes when device is on but | ||||
| no pulses are being applied |